MAUDE Adverse Event Report: STRYKER SPINE-US POSTERIOR LUMBAR CAGE 9MM X 23MM X6DEG - 9MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	48950096
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that a tritanium pl cage at l5 fractured one year postoperatively.Revision surgery has not occurred.
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that a tritanium pl cage at l5 fractured one year postoperatively.Revision surgery has not occurred.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.It was reported that a tritanium pl cage at l5 fractured one year postoperatively.Revision surgery has not occurred.A minimum of three follow up attempts were performed to obtain additional information, but no response was received.Due to lack of information and device not returned, an exact cause of the reported event could not be determined.Potential causes include: extreme surgical techniques outside of the approved ifu used during insertion that result in a cracked cage being implanted, but not identified at the time of implantation/ excess post-op activity by patient/ patient fall or external trauma, etc.

• Brand Name: POSTERIOR LUMBAR CAGE 9MM X 23MM X6DEG - 9MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 13667299
• Report Number: 3004024955-2022-00001
• Device Sequence Number: 14796434
• Product Code: MAX
• UDI-Device Identifier: 07613327117318
• UDI-Public: 07613327117318
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 48950096
• Device Catalogue Number: 48950096
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown